Regeneron and Sanofi partnership awarded US FDA breakthrough therapy designation for cemiplimab for squamous cell carcinoma.
M2 PHARMA-September 11, 2017-Regeneron and Sanofi partnership awarded US FDA breakthrough therapy designation for cemiplimab for squamous cell carcinoma
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Biotechnology company Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi Friday jointly reported the receipt of US Food and Drug Administration (FDA) breakthrough therapy designation status for cemiplimab (REGN2810) for the treatment of metastatic cutaneous squamous cell carcinoma (CSCC).
According to the companies, Cemiplimab, which is an investigational human, monoclonal antibody targeting PD-1, is being indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer after melanoma.
Currently, cemiplimab is under clinical development and its safety and efficacy has not been fully evaluated by any regulatory authority, added the companies.
In June 2017, the companies reported positive, preliminary results for cemiplimab from two expansion cohorts involving 26 advanced CSCC patients in a Phase 1 study of nearly 400 patients, at the American Society of Clinical Oncology (ASCO) Annual Meeting
Additionally, EMPOWER-CSCC 1, a Phase 2, potentially pivotal, single-arm, open-label clinical trial of cemiplimab is currently enrolling patients with metastatic CSCC and locally advanced and unresectable CSCC, revealed the company.
Cemiplimab was discovered using Regeneron's proprietary VelocImmune technology that yields optimized fully-human antibodies and is being jointly developed by with Sanofi under a global collaboration agreement. The companies plan submitting a biologics license application for cemiplimab with the US FDA in the Q1 2018.
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|Date:||Sep 11, 2017|
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